SuspendedNCT03860285Updated Mar 14, 2023

Objective and Perceived Quality Study in Patients Undergoing Elective Groin Hernia Surgery

An observational study in Inguinal Hernia, Quality of Life and Surgery, sponsored by Hospital of Navarra. Suspended at 1 site in Spain. Open to participants aged 16 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-03-14.

Sponsored by Hospital of Navarra · Observational

Why this study was suspended

Pending changes in recruitment

Study type: Observational
Model: Cohort
Time perspective: Prospective
Enrollment: 850
Ages: 16 Years and older
Sex: All

Study summary

This is a prospective non-comparative observational study of cohorts. Consists on offering surveys to every patient undergoing groin hernia surgery in our Abdominal Wall Surgery Unit, in Hospital of Navarra.

Read the detailed description

HYPOTHESIS:

The objective and perceived quality data of the patients under study (adult patients undergoing scheduled inguinal hernia without complications) in Pamplona are within the international quality standards.

OBJECTIVES

Primary objective:

-Obtaining data of objective and perceived quality of patients undergoing elective groin hernia surgery in Pamplona durinag a year to compare them with international quality standards.

Secondary objectives:

Obtaining data on duration of sick leave (temporary disability due to common contingency) associated with the referred procedures, as well as their possible complications.
Assess the costs associated with the intervention and its possible complications.
Raise options (if necessary and feasible) to improve the results exposed obtained by our service.

Conditions studied

Inguinal Hernia
Quality of Life
Surgery
Survey

Browse trials for

Hernia, Inguinal 561

Keywords

inguinal hernia
quality of life
survey
surgery
pamplona
prospective
observational
cohorts

In context

Hernia, Inguinal

561 studies on the registry are indexed under Hernia, Inguinal; 76 are open to participants now.

This study's planned enrollment of 850 is above the median of 150 across 137 observational studies indexed under Hernia, Inguinal.

Browse Hernia, Inguinal studies →

Lead sponsor

Hospital of Navarra is the lead sponsor of 8 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 16 Years and older
Sexes eligible: All
Accepts healthy volunteers: Yes
Sampling method: Probability sample

Study population

Patients undergoing elective inguinal hernia surgery en Pamplona

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Patients entering surgical waiting list during a year (from March 1st, 2018, to February 28th, 2019).
Elective surgery.

Exclusion criteria

Exclusion Criteria:

Age below 16.
Mental diseases.
Patients not capable of understanding the study.
Patients that reject entering the study.

Study design

Observational model: Cohort
Time perspective: Prospective
Enrollment: 850 participants (estimated)
Target follow-up: 4 Years
Patient registry: Yes

Interventions

OtherShort form 36 quality of life survey
Prospective non-comparative observational study of cohorts
Also known as: European Hernia Society Survey

What researchers measure

Primary outcomes

Obtaining objective and perceived quality of life
Obtaining data about objective and perceived quality of life of patients undergoing elective inguinal hernia surgery in Pamplona during a year to compare them with international quality standards
Time frame: 4 years

Secondary outcomes

Knowing patients' pain
Level of pain, before and after surgery
Time frame: 4 years
Registering hernia recurrence
Percentage of patients with hernia recurrence during study surveillance
Time frame: 4 years
Controlling presence or not of complications
Presence or not of postop complicationes
Time frame: 4 years
Knowing patient satisfaction
Grade of patient satisfaction with surgery result
Time frame: 4 years
Knowing duration of sick leave
How long is sick leave
Time frame: 4 years
Knowing waiting time for surgery
Patient waiting time until surgery date
Time frame: 4 years

Study locations

1 site

Hospital de navarra
Pamplona, Navarre 31003, Spain

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reached

Started Mar 2018 (actual). Primary completion is estimated for Dec 2023, 69 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered: Dec 2, 2018
First posted: Mar 1, 2019
StartActual: Mar 1, 2018
Primary completionEst.: Dec 31, 2023
CompletionEst.: Dec 31, 2023
Last update: Mar 14, 2023

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Mar 14, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03860285
Lead sponsor: Hospital of Navarra
Responsible party: Gorka Docio (General Surgeon, Senior, Hospital of Navarra) — Principal investigator
First posted: Mar 1, 2019
Start date: Mar 1, 2018
Primary completion: Dec 31, 2023 (estimated)
Completion: Dec 31, 2023 (estimated)
Last update: Mar 14, 2023

Study contacts

Concepción Yárnoz-Irazabal, PhD

study director · Hospital de Navarra

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is suspended, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.

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Discussion

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